Beckman Coulter Flow Cytometers Recalled for Amplifier Board Defect
Beckman Coulter is recalling Cytomics FC 500 and EPICS XL flow cytometers due to a manufacturing defect on the amplifier board that may cause signal loss or drifting.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application."
Plain-English summary
Beckman Coulter Inc. is recalling Cytomics FC 500 and EPICS XL flow cytometers used for in vitro diagnostics. The recall involves 3,115 units distributed worldwide, including the United States and Puerto Rico.
The recall is due to a manufacturing defect on the amplifier board that may cause signal loss and/or signal drifting. This defect can result in the absence of data or a population shift in data plots, which may impact patient results for any application.
Healthcare facilities and users of these devices should contact Beckman Coulter for further instructions on how to address the defect.
The recalled product
- Product
- 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics
- Manufacturer
- Beckman Coulter Inc.
- Category
- Medical Device — Flow Cytometer
- Affected units
- 3,115
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Remfg Assy
- 5 Clr (220V) A89264 FC 500" Flow Cytometer 100-240V
- 50-60HZ
- Remfg Assy A89151 FC 500 Recond MCL UPS Flow Cytometer 100-240V
Distribution
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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